Senior Statistician
Core
Design, deliver, and interpret statistical analyses for preclinical and clinical programs, regulatory submissions, and commercialization in the pharmaceutical industry.
Role type
Senior individual contributor statistician (pharmaceuticals)
Builds
Statistical analysis plans, regulatory submission documents, study reports, and decision criteria models
Domain
Pharmaceuticals / Clinical Research / Biostatistics
Required skills
Complex study design, statistical modeling and simulation, regulatory submission expertise, mentoring less experienced staff, cross-functional collaboration, statistical analysis plan development, data interpretation and communication, methodology improvement, best practice development
Preferred skills
Creative statistical idea generation, novel statistical approach investigation, external scientific community collaboration, conference and journal publication participation, process improvement leadership
Technologies
Statistical software (implied by modeling/simulation context)
Responsibilities
Provide statistical expertise for complex design and interpretation of preclinical or clinical programs; Analyze internal and external information to perform modeling and simulation for design decisions; Develop Statistical Analysis plans for complex studies; Act as a coach/guide for less experienced statisticians; Contribute to regulatory submissions including specification of overview documents; Identify opportunities to apply modeling and simulation to improve study design; Investigate and apply novel statistical approaches for regulatory guidance or value demonstration; Communicate research and results internally and externally through conferences and publications.
Seniority
Senior, hands-on IC with mentorship responsibilities